with solanezumab. J Alzheimers Dis 34, 897-910. [41] Lewczuk P, Kornhuber J, Vanmechelen E, Peters O, Heuser. I, Maier W, Jessen F, Burger K, Hampel H, ...
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Journal of Alzheimer’s Disease 54 (2016) 751–762 DOI 10.3233/JAD-160325 IOS Press
Validation of Immunoassay-Based Tools for the Comprehensive Quantification of A40 and A42 Peptides in Plasma Virginia P´erez-Grijalba1 , Noelia Fandos1 , Jes´us Canudas, Daniel Insua, Diego Casabona, Ana M. Lacosta, Mar´ıa Monta˜ne´ s, Pedro Pesini∗ and Manuel Sarasa Araclon Biotech, Zaragoza, Spain
Accepted 15 June 2016
Abstract. Recent advances in neuroimaging and cerebrospinal fluid (CSF) biomarker assays have provided evidence of a long preclinical stage of Alzheimer’s disease (AD). This period is being increasingly targeted for secondary prevention trials of new therapies. In this context, the interest of a noninvasive, cost-effective amyloid- (A) blood-based test does not need to be overstated. Nevertheless, a thorough validation of these bioanalytical methods should be performed as a prerequisite for confident interpretation of clinical results. The aim of this study was to validate ELISA sandwich colorimetric ABtest40 and ABtest42 for the quantification of A40 and A42 in human plasma. The validation parameters assessed included precision, accuracy, sensitivity, specificity, recovery, and dilution linearity. ABtest40 and ABtest42 proved to be specific for their target peptide using A peptides with sequence similar to the target. Mean relative error in the quantification was found to be below 7.5% for both assays, with high intra-assay, inter-assay, and inter-batch precision (CV
